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Does treadmill-based gait training with the Incedo-system improve walking performance and gait parameters in subacute stroke patients with severe hemiparesis who are unable to walk independently

Does treadmill-based gait training with the Incedo-system improve walking performance and gait parameters in subacute stroke patients with severe hemiparesis who are unable to walk independently

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031910
Enrollment
50
Registered
2023-06-15
Start date
2024-04-05
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I60 I61 I62 I63 I64

Interventions

Group 1: Intervention group: Gait training on the treadmill, under weight relief with the Incedo-system, 2x per week, 30 minutes for 6 weeks. Group 2: Control group: Gait training on the treadmill, un

Sponsors

Lurija Institut, Kliniken Schmieder
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Stroke < 6 months - Patients who can only walk with the permanent support of at least one assistant (FAC 0-1) - Patients with whom treadmill-assisted gait training can be carried out with weight support - Patients are trunk stable (item sitting from the Trunk Control Test = 25 points) - Patient is able to tolerate electrostimulation. - Visible response to stimulation both sitting and walking - Ability to give consent to participate in the study and to follow instructions - Ability to communicate - Electrostimulation is only used with the consent of the doctor treating the patient

Exclusion criteria

Exclusion criteria: - More than one stroke in the history, unless the patient has no neurological deficits from the previous strokes. - Other neurological diseases - Lack of compliance - Epilepsy - Patients with heart pacemakers - Patients with severe heart or lung diseases - Patients with cancer - Skin lesions in the area where the electrode is positioned - Pregnancy - Patients who adjust to the electrical stimulus in a short time or patients in whom a higher stimulation intensity triggers spasticity or clonus in the affected leg

Design outcomes

Primary

MeasureTime frame
The aim of the study is to determine whether treadmill-based gait training in combination with electrical stimulation of the foot sole, with the Incedo-system, leads to an improvement in the walking performance and gait parameters of patients after stroke who are unable to walk independently. There is a baseline-test before the start of the training and a post-test directly after the six weeks of training. A follow-up test is conducted after a further six weeks. The following parameters are recorded at each test time: - Modified muscle function test - Somatosensory test - Measurement of spasticity (Tardieu-Scale) - Assessment of walking ability (Functional Ambulation Categories) - Two-minute walking test on the treadmill (with and without Incedo-system). With recording of: a) Amount of weight relief b) Distance covered c) Number of steps d) Degree of exertion for patients (BORG scale) e) Degree of effort for therapists (questionnaire) - Video recordings of the muscle strength of the affected leg as well as the patient's gait pattern on the floor and the treadmill. - Sensory evoked potentials (SEP) of N. tibialis

Countries

Germany

Contacts

Public ContactJana Stürner

Lurija Institut, Kliniken Schmieder Allensbach

j.stuerner@kliniken-schmieder.de07533 808 1404

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026